| CTRI Number |
CTRI/2025/07/091140 [Registered on: 18/07/2025] Trial Registered Prospectively |
| Last Modified On: |
18/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing the Effects of Work Hours on Sleep Quality, Dietary Habits, and cholesterol levels in Surgical vs Non-Surgical Resident Physicians of Mumbai and Goa Medical College and Hospital. |
|
Scientific Title of Study
|
A comparative study on Impact of Work hours on Sleep Quality, Dietary Habits, and Risk of Dyslipidemia as a biomarker between Surgical and Non-surgical Resident Physicians of Mumbai and Goa Medical College and Hospital. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Siddhi Gawas Gaonkar |
| Designation |
Student |
| Affiliation |
Dr. B.M.N. College of Home Science |
| Address |
Dr. BMN College of Home Science, Department of Clinical Nutrition and Dietetics, 338 R.A. Kidwai Marg, Matunga East, Mumbai, Maharashtra 400019
Dr. BMN College of Home Science, Department of Clinical Nutrition and Dietetics, 338 R.A. Kidwai Marg, Matunga East, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9607196792 |
| Fax |
|
| Email |
siddhigawas0899@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rupali Sengupta |
| Designation |
Head of Department |
| Affiliation |
Dr. B.M.N. College of Home Science |
| Address |
Dr. BMN College of Home Science, Department of Clinical Nutrition and Dietetics, 338 R.A. Kidwai Marg, Matunga East, Mumbai, Maharashtra 400019
Dr. BMN College of Home Science, Department of Clinical Nutrition and Dietetics, 338 R.A. Kidwai Marg, Matunga East, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9892415789 |
| Fax |
|
| Email |
rupali@bmncollege.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rupali Sengupta |
| Designation |
Head of Department |
| Affiliation |
Dr. B.M.N. College of Home Science |
| Address |
Dr. BMN College of Home Science, Department of Clinical Nutrition and Dietetics, 338 R.A. Kidwai Marg, Matunga East, Mumbai, Maharashtra 400019
Dr. BMN College of Home Science, Department of Clinical Nutrition and Dietetics, 338 R.A. Kidwai Marg, Matunga East, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9892415789 |
| Fax |
|
| Email |
rupali@bmncollege.com |
|
|
Source of Monetary or Material Support
|
| Dr. B.M.N. College of Home Science |
|
|
Primary Sponsor
|
| Name |
Siddhi Gawas Gaonkar |
| Address |
338, R.A. Kidwai Road, Matunga, Mumbai- 400019 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rupali Sengupta |
Dr. B.M.N. College of Home Science |
Dr. BMN College of Home Science, Department of Clinical Nutrition and Dietetics, 338 R.A. Kidwai Marg, Matunga East, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA |
9892415789
rupali@bmncollege.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seva Mandal Education Society Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Resident Physicians with no disease condition |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
Observational study, no intervention is involved |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Healthy Resident Physicians with no disease condition |
|
| ExclusionCriteria |
| Details |
Resident Physicians other than Mumbai and Goa Medical College and Hospital.
Resident Physicians with disease condition.
Participants below 25 and above 30 years of age.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the impact of work hours on sleep quality, dietary habits and risk of dyslipidemia as a biomarker between surgical and non-surgical resident physicians of Mumbai and Goa Medical College and Hospital. |
At time of data collection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess the effect of work hours on the sleep quality among resident physicians using Pittsburgh sleep quality index (PSQI).
2.To examine the impact of work hours on the dietary habits of resident physicians using Global diet quality score (GDQS).
3.To determine the correlation of work hours with, sleep quality & dietary intake & risk of dyslipidemia as a biomarker amongst surgical & non-surgical resident physicians. |
At the time of data collection |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This research proposal, titled " A comparative study on Impact of Work hours on Sleep quality, Dietary Habits, and risk of dyslipidemia as a biomarkers between Surgical and Non- surgical Resident Physicians of Mumbai and Goa Medical College and Hospital ", aims to assess the Impact of Work hours on Sleep quality, Dietary Habits, and risk of dyslipidemia as a biomarkers between Surgical and Non- surgical Resident Physicians of Mumbai and Goa Medical College and Hospital. The Hypothesis is that there is no significant association between workhours on sleep quality, dietary habits and lipid profile between surgical and non surgical Resident Physicians. The Expected outcome is that work hours may significantly affect sleep quality, Unhealthy dietary habits, and higher risk of dyslipidemia as a biomarker in surgical residents as compared to non- surgical Residents.
|